A German company has become the first to score FDA approval for a stand-alone prosthetic iris in the United States.

The agency said Wednesday afternoon that it approved the CustomFlex Artificial Iris, made by Erlangen, Germany-based HumanOptics. The device, which is surgically implanted, is approved to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at FDA's Center for Devices and Radiological Health. “Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent. It affects about 1 in 50,000 to 100,000 people in the United States, according to FDA. The iris controls the amount of light entering the eye, and those with aniridia have a sensitivity to light and other severe vision problems. In addition to congenital aniridia, the CustomFlex Artificial Iris is indicated to treat iris defects due to other reasons or conditions, such as albinism, traumatic injury, or surgical removal due to melanoma.

The CustomFlex Artificial Iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient. A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures.

The agency said it based its approval decision on safety and effectiveness data from a non-randomized trial of 389 adult and pediatric patients with aniridia or other iris defects. The study measured patients’ self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis. More than 70% of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure. In addition, 94% of patients were satisfied with the artificial iris’ appearance.

The study found low rates of adverse events associated with the device or the surgical procedure, FDA noted. But the device-related complications that were reported in the study included device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae). In some cases, these complications led to a second surgery to reposition, remove, or replace the device.

There were also complications associated with the surgical procedure, such as increased intraocular pressure, blood leakage in the eye, swelling of the center of the retina (cystoid macular edema), corneal swelling, iritis, and retinal detachment.

The CustomFlex Artificial Iris is contraindicated, or should not be used, in eyes with any of the following conditions: uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris (rubeosis), certain kinds of damaged blood vessels in the retina, and intraocular infections. It is also contraindicated for patients who are pregnant.

The CustomFlex Artificial Iris was approved through a premarket approval application (PMA), which is the most stringent type of device marketing application and generally required for high-risk devices. FDA usually bases a PMA approval on scientific evidence that provides reasonable assurance that the device is safe and effective for its intended uses.

Because the device received the agency's breakthrough device designation, FDA provided intensive interaction and guidance to the company on efficient device development to expedite evidence generation and the agency’s review of the device.

To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. The device also has to either represent a breakthrough technology, offer significant advantages over existing alternatives that are approved or cleared for marketing (if there are any), or be something FDA determines is in the best interest of patients.